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The Establishment of Hong Kong Diabetes Steatotic Liver Disease Register

The Establishment of Hong Kong Diabetes Steatotic Liver Disease Register

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07437157
Enrollment
1000
Registered
2026-02-27
Start date
2025-06-11
Completion date
2027-02-28
Last updated
2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease, Type 2 Diabetes (T2DM)

Brief summary

Liver is an important organ in maintaining energy homeostasis. Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), formerly known as non-alcoholic fatty liver disease (NAFLD), is the most common chronic liver disease locally and globally. MASLD and type 2 diabetes mellitus (T2DM) are closely related with alarmingly high prevalence of MASLD in people with T2DM, along with the escalated risk of adverse clinical outcomes. Our group has reported that around 70% of people with T2DM have increased controlled attenuation parameter (CAP) suggestive of hepatic steatosis and one out of six had advanced liver fibrosis as evidenced by increased liver stiffness measurements (LSM). Despite its prevalence, close relationships and potential consequences, the mechanisms underlying the complex interconnections between MASLD and T2DM are not fully understood. MASLD is associated with a twofold higher risk of developing T2DM, independent of obesity and other common metabolic risk factors. This risk increases with the severity of MASLD, such that patients with more advanced stages of liver fibrosis are at a higher risk of developing T2DM. Moreover, the progression from hepatic steatosis to fibrosis is an important, yet not fully understood, step towards cirrhosis and end-stage liver disease. Identification of clinical predictors and biomarkers to select individuals with MAFLD for close monitoring is pivotal to prevent the sinister outcomes. To date, longitudinal cohorts with paired biobank focused on people with diabetes and comorbid MASLD for investigating the clinical courses and biomarkers for prediction of outcomes are lacking. We hypothesized that Hong Kong Chinese T2DM with comorbid steatotic liver disease have unique clinical courses and special biomarkers for predicting the progression to advanced liver fibrosis. The aims of this study are: 1) establish a prospective cohort of people with T2DM and comorbid steatotic liver disease accompanied with the setting up of a biobank; 2) elucidate the clinical courses and outcomes of Hong Kong Chinese T2DM with comorbid steatotic liver disease; 3) identify potential diagnostic markers of advanced liver fibrosis in people with T2DM and comorbid steatotic liver disease in Hong Kong. The primary outcome measure will be all-cause mortality and secondary outcome measure will be fatal and non-fatal CVD, heart failure, hospitalizations, NT-proBNP levels, and novel diagnostic markers of MASH in people with T2DM comorbid with MASLD.

Interventions

OTHERNo intervention (observational study)

There is no intervention involved in this observational study.

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* T2DM. * Aged ≥ 18 years. * Able and willing to give Informed written consent.

Exclusion criteria

* Type 1 diabetes. * Terminal illness such as malignancy with limited life expectancy. * Any condition, as judged by the investigators, as ineligible to participate in this study.

Design outcomes

Primary

MeasureTime frameDescription
All-cause mortality15 yearsDeath from any cause collected from hospital electronic medical record.

Secondary

MeasureTime frameDescription
Fatal and non-fatal cardiovascular disease15 yearsIncidence of fatal and non-fatal cardiovascular disease collected from hospital electronic medical record
Heart failure15 yearsIncidence of heart failure collected from hospital electronic medical record
Hospitalizations15 yearsIncidence of hospitalizations collected from hospital electronic medical record
NT-proBNP levelsBaselineNT-proBNP levels collected from blood sample
Novel diagnostic markers of Metabolic dysfunction-associated steatohepatitis related to bile acid metabolismBaselineNovel diagnostic markers of Metabolic dysfunction-associated steatohepatitis, related to bile acid metabolism, collected from blood sample. The novel biomarkers, cannot be disclosed in detail because the funding support is still pending (Project reference:T12-202/23-R). You can check on the website Theme-based Research Scheme (https://www.ugc.edu.hk/eng/rgc/funding\_opport/trs/index.html) to enquire about what can be disclosed to the public.

Countries

Hong Kong

Contacts

CONTACTAlice Pik Shan Kong, MD
alicekong@cuhk.edu.hk+852 3505 2648

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026